PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease (PD-HF)

PD-HF: A Multi-centre Randomised Controlled Trial of Intermittent Peritoneal Dialysis With Icodextrin-based Solutions on Patients With Severe Heart Failure and Stage 3-4 Chronic Kidney Disease

This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Chronic Kidney Disease
• Intervention / Treatment: Procedure: Peritoneal Dialysis

Detailed Description

The trial is a multi-centre, prospective, randomised, unblended, controlled trial of intermittent PD with a single daily exchange of icodextrin plus best standard care versus best standard care for the treatment of severe HF and moderate CKD. A second exchange with glucose based solution may be given, should it be required in the investigator's/clinician's opinion. Investigators will randomise 130 participants for 32 weeks with randomisation stratified by participating centre. Participants will be recruited from specialist-led outpatient HF services in 6 NHS trusts and be managed by both cardiologists and nephrologists.

PD catheter insertion will occur according to the participating centre's institutional protocol. Treatment begins 1 week after catheter insertion and consists of a single nightly exchange.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3DT
      • Derby Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Severe heart failure (NYHA grade III or IV)
• Chronic kidney disease stage 3-4
• Fluid overload resistant to diuretics OR hospital admission for HF in last 6 months
• Left ventricular ejection fraction ≤40% in last 2 years (moderate/severe)
• Using optimal HF medication for ≥ 4 weeks including ACE-inhibitor (angiotensin-converting-enzyme inhibitor) OR angiotensin receptor blocker AND aldosterone antagonist AND beta-blocker unless intolerant and without dose change for ≥ 4 weeks
• Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated.

Exclusion Criteria:

• Does not wish to participate
• Mental incapacity to consent
• CKD stage 5
• Normal renal excretory function
• Haemodynamically significant valvular disease amenable to surgery
• Cardiac or renal transplantation
• Considered by the investigator to unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peritoneal Dialysis Group; These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.	Procedure: Peritoneal Dialysis; One week after insertion of a PD catheter the intervention group will received a single nightly exchange, using dialysis fluid containing icodextrin; a variable proportion of participants may require a second exchange as directed by the consultant nephrologist as part of routine care. The second exchange would use dialysis fluid containing glucose, not icodextrin. Support and training will be given to each participant by the PD specialist team.
No Intervention: Control Group; These participants will continue to receive standard HF care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary end-point is a change of 25 metres walked	6 Minute Walk Test	Baseline to week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in KCCQ score	Kansas City Cardiomyopathy Questionnaire	Baseline to week 28
Change in SF36 score	Short Form 36 questionnaire	Baseline to week 28
Change in Derby Evaluation of Illness online visual analogue scale	Derby Evaluation of Illness online visual analogue scale	Baseline to week 28
Heart Failure related hospitalisations	Recording the number of hospitalisations relating to Heart Failure	Baseline to week 28
All cause hospitalisations	Recording the number of hospitalisations for all causes	Baseline to week 28
Heart failure related mortality	Recording the number of heart failure deaths	Baseline to week 28
All cause mortality	Recording the number of all cause deaths	Baseline to week 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes of PD associated peritoneal infection	Recording the numbers of PD associated peritoneal infections	Baseline to week 28
Adverse events spontaneously reported during the study	Recording and reporting adverse events	Baseline to week 28
Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires	Comparison between the scores from pen and ink questionnaires and the online visual analogue scale	Baseline to week 28

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: British Heart Foundation
• Investigators: Principal Investigator: Maarten Taal, University of Nottingham

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency; Heart Failure; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: IRAS project ID: 158992; ref: PG/13/27/29864 (Other Grant/Funding Number: BHF grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED